Draft Guidance for Industry and Reviewers on Structured Product Labeling Standard for Content of Labeling Technical Questions and Answers
IMPLEMENTATION NOTE [02-Nov-2009]: In the very near future, all valid new listing SPL documents associated with approved drug products should be posted for you to access via this link within 24 - 48 hours on business days. If you need the document posted right away for a submission then you can let us know via e-mail to//SPL@fda.hhs.gov//. In that e-mail, you should send the document ID associated with the submission and we should be able to have it posted within a few hours after it is processed by the eList system. FDAshould have all of the valid listing documents submitted prior to last week in the new repository within three weeks.